Table 2

Summary of safety events (all causality) up to months 3 and 12 for patients receiving tofacitinib 5 mg two times per day, 10 mg two times per day and placebo, by sex*; pooled data from OPAL Broaden and OPAL Beyond

Up to month 3Tofacitinib 5 mg two times per dayTofacitinib 10 mg two times per dayPlacebo
Patients with events,
n (%)
Male (N=117)Female (N=121)Male (N=100)Female (N=136)Male (N=100)Female (N=136)
TEAEs55 (47.0)59 (48.8)44 (44.0)73 (53.7)30 (30.0)65 (47.8)
SAEs2 (1.7)2 (1.7)3 (3.0)1 (0.7)04 (2.9)
Discontinuation due to AEs1 (0.9)2 (1.7)2 (2.0)5 (3.7)3 (3.0)1 (0.7)
Deaths000000
Serious infections001 (1.0)1 (0.7)00
HZ (serious and non-serious)†1 (0.9)1 (0.8)01 (0.7)00
OIs (excluding TB)1 (0.9)‡00000
TB000000
MACE000000
Malignancies (excluding NMSC)1 (0.9)1 (0.8)0000
NMSC000000
GI perforations000000
VTEs000000
Up to month 12Tofacitinib 5 mg two times per dayTofacitinib 10 mg two times per day
Patients with events,
n (%)
Male (N=117)Female (N=121)Male (N=100)Female (N=136)
TEAEs79 (67.5)85 (70.2)70 (70.0)99 (72.8)
SAEs4 (3.4)8 (6.6)4 (4.0)8 (5.9)
Discontinuation due to AEs3 (2.6)8 (6.6)4 (4.0)7 (5.1)
Deaths0000
Serious infections02 (1.7)1 (1.0)2 (1.5)
HZ (serious and non-serious)†1 (0.9)2 (1.7)2 (2.0)2 (1.5)
OIs (excluding TB)§1 (0.9)‡000
TB0000
MACE¶0001 (0.7)
Malignancies (excluding NMSC)1 (0.9)2 (1.7)00
NMSC001 (1.0)0
GI perforations0000
VTEs0000
  • *Includes all patients from OPAL Broaden and OPAL Beyond who were randomised at baseline to tofacitinib 5 mg two times per day, 10 mg two times per day or PBO.

  • †No serious events of HZ were reported in males or females receiving tofacitinib 5 mg or 10 mg two times per day.

  • ‡Moderate HZ (three dermatomes affected).

  • §One adjudicated OI (multidermatomal HZ, two adjacent dermatomes) occurring in a female patient receiving tofacitinib 5 mg two times per day in OPAL Broaden was reclassified as a ‘Special Interest Infection’ and included in HZ (serious and non-serious).

  • ¶One MACE was reported in a male patient receiving tofacitinib 5 mg two times per day outside the 28-day risk period.

  • AEs, adverse events; GI, gastrointestinal; HZ, herpes zoster; MACE, major adverse cardiovascular events; N, number of patients included in the analysis; n, number of patients with the event (events are counted up to 28 days beyond the last dose or the end of month 3 or month 12); NMSC, non-melanoma skin cancer; OIs, opportunistic infections; PBO, placebo; SAEs, serious adverse events; TB, tuberculosis; TEAEs, treatment-emergent adverse events; VTEs, venous thromboembolic events.